Study to evaluate the safety and tolerability of XRD-0394 in combination with palliative radiation therapy
Major milestone for the company with first asset reaching clinical development
DURHAM, NC, August 24, 2021 – XRad Therapeutics, a privately-held, clinical stage biopharmaceutical company focused on developing dual kinase inhibitors for treating cancer, today announced that the first patient has been dosed in the company’s Phase 1a trial evaluating XRD-0394 in combination with radiation therapy (RT) for the treatment of metastatic, locally-advanced or recurrent solid tumors. XRD-0394 is a first-in-class, oral, dual kinase inhibitor of both ataxia-telangiectasia mutated (ATM) and DNA-dependent protein kinase (DNA-PK) and based on preclinical studies is designed to enhance the effectiveness of radiation therapies.
“More than 50% of cancer patients receive radiation therapy as part of their treatment regimen. Despite its widespread use, high unmet needs still exist in many tumor types,” said Tona Gilmer, PhD, president, chief executive officer and co-founder of XRad. “We look forward to continuing the development of XRD-0394 as we transition into clinical trials.”
The Phase 1a trial is an open-label, multicenter study designed to evaluate the safety and tolerability of single ascending doses of XRD-0394 administered with palliative RT in patients with metastatic, locally advanced or recurrent cancer. Results from this study will inform the dosing regimen for the company’s planned Phase 1b study.
Radiation therapy is one of the most widely used approaches for treating cancer and works by damaging the DNA of tumor cells. ATM and DNA-PK play critical roles in DNA repair and become activated after exposure to radiation therapy. In preclinical studies, XRD-0394 improved the effectiveness of radiation therapy by blocking these two key repair enzymes.
The Phase 1a study is being conducted at two centers, Memorial Sloan Kettering Cancer Center and the Stanford Cancer Institute, with support from our partners at Aptus Clinical. For more information about the study, please visit www.clinicaltrials.gov (NCT05002140). XRD-0394 is not approved for any condition at this time.
About XRad Therapeutics
XRad Therapeutics is a privately-held, clinical stage biopharmaceutical company focused on developing dual kinase inhibitors for treating cancer. The company’s lead candidate, XRD-0394, is a first-in-class dual inhibitor of ataxia-telangiectasia mutated (ATM) and DNA-dependent protein kinase (DNA-PK). Initial development efforts are focused on evaluating XRD-0394’s ability to enhance radiation therapy when used in combination. In parallel, the company is exploring the potential benefits of using XRad’s dual kinase inhibitors in combination with targeted radionuclides, checkpoint inhibitors, poly adenosine diphosphate-ribose polymerase (PARP) inhibitors and antibody drug conjugates (ADCs).